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Biotechnology
M&A continued to feature in the news last week, as Gilead Sciences announced plans to acquire fellow USA-based CymaBay Therapeutics and its liver disease candidate seladelpar for around $4.3 billion. On a negative development, AN2 Therapeutics saw its market capitalization crash 74% after it revealed it is pausing enrollment of a Phase III study of epetraborole in lung cancer, Also of note, Brii Biosciences announced another research collaboration with VBI Vaccines in lung cancer. Sarepta Therapeutics announced that the US Food and Drug Administration (FDA) has accepted its application for an extended indication for its Duchenne muscular dystrophy drug Elevidys. 18 February 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Xolair (omalizumab) for the reduction of allergic reactions to one or more foods , Swiss pharm giant Roche announced on Friday. 17 February 2024
Biotechnology
The Food and Drug Administration (FDA) has accepted and filed the efficacy supplement to the Biologics License Application (BLA) for Elevidys (delandistrogene moxeparvovec-rokl) submitted by US precision genetic medicines firm Sarepta Therapeutics. 16 February 2024
Biotechnology
The US Food and Drug Administration yesterday revealed it has granted traditional approval for Tepmetko (tepotinib,) from EMD Serono, a US subsidiary of Germany’s Merck KGaA. 16 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro (repotrectinib). 16 February 2024
Biotechnology
The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. 16 February 2024
Biotechnology
US biopharma Citius Pharmaceuticals has announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Lymphir (denileukin diftitox) for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. 15 February 2024
Pharmaceutical
Today, the US Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. 14 February 2024
Biotechnology
The US Food and Drug Administration (FDA) has extended the Priority Review period for the Biologics License Application (BLA) for Kresladi (marnetegragene autotemcel; formerly RP-L201) for severe leukocyte adhesion deficiency-I (LAD-I). 14 February 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Onivyde (irinotecan liposome), from French drugmaker, in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX regime), for the first-line treatment of metastatic pancreatic adenocarcinoma (mPDAC). 14 February 2024
Pharmaceutical
Japanese pharma major Takeda has announced that the US Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). 13 February 2024
Biotechnology
Genetic disease company Vertex Pharmaceuticals has secured conditional marketing authorization for Casgevy (exagamglogene autotemcel) in Europe. 13 February 2024
Pharmaceutical
The European Commission (EC) has authorized Biogen’s Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. 13 February 2024
Biotechnology
On Friday, the US Food and Drug Administration (FDA) issued a final rule to amend its regulations concerning the use of master files for biological products. 12 February 2024
Generics
Following an inspection from the US medicines regulator, a manufacturing site run by Indian active pharmaceutical ingredient (API) specialist Aparna Pharmaceuticals has received a VAI classification. 12 February 2024
Pharmaceutical
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with the COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir). 9 February 2024
Biotechnology
Crovalimab, a humanized complement inhibitor C5 monoclonal antibody discovered by Japan’s Chugai Pharmaceutical (TYO: 4519), has been approved by China’s National Medical Products Administration (NMPA) for treatment of PNH. 8 February 2024
Biotechnology
Gilead Sciences announced it has discontinued the Phase III ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML). 8 February 2024
Biotechnology
Hong Kong-listed biotech BeiGene has received Health Canada authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL). 8 February 2024
Biotechnology
The UK's Medicines and Healthcare Regulatory Agency (MHRA) has licensed subcutaneous (SC) injectable Vyvgart (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. 7 February 2024
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (trade name Eqjubi) to treat adult patients with a type of cancer called non-small cell lung cancer (NSCLC ). 31 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024
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